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<p>Glecirasib (JAB-21822) is a new covalent oral KRAS-G12C inhibitor. This multicenter, single-arm phase 2b study assessed the efficacy and safety of glecirasib administered orally at 800 mg daily in patients with locally advanced or metastatic <i>KRAS</i><sup>G12C</sup>-mutated nonsmall-cell lung cancer. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee (IRC). Between 15 September 2022 and 28 September 2023, 119 patients with a median age of 62 years were enrolled. As of the data cut-off date on 28 March 2024, the ORR assessed by IRC was 47.9% (56/117; 95% confidence interval: 38.5–57.3%). The incidence of treatment-related adverse events (TRAEs) of any grade was 97.5% (116/119). The incidence of grades 3 and 4 TRAEs was 38.7% (46/119). A total of 5.0% (6/119) of patients discontinued the treatment due to TRAEs. No treatment-related deaths occurred. Glecirasib exhibited promising clinical efficacy and manageable safety profiles in these patient populations. ClinicalTrials.gov identifier: <a href="https://clinicaltrials.gov/search?term=NCT05009329">NCT05009329</a>.</p>

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Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial

  • 期刊论文

  • 发表日期：

    2025年1月6日

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  • Yuankai Shi,
  • Jian Fang,
  • Ligang Xing,
  • Yu Yao,
  • Jian Zhang,
  • Lian Liu,
  • Yongsheng Wang,
  • Changlu Hu,
  • Jianping Xiong,
  • Zhihua Liu,
  • Runxiang Yang,
  • Zhen Wang,
  • Enfeng Zhao,
  • Mengzhao Wang,
  • Yanqiu Zhao,
  • Kejing Tang,
  • Zhihua Li,
  • Zhengbo Song,
  • Yongsheng Li,
  • Wu Zhuang,
  • Bo Jin,
  • Ying Cheng,
  • Yanping Hu,
  • Yanhong Gu,
  • Lin Wu,
  • Rui Ma,
  • Qitao Yu,
  • Yan Yu,
  • Jun Zhao,
  • Hui Zhao,
  • Dongqing Lv,
  • Yanhong Shang,
  • Puyuan Xing,
  • Jin Zhou,
  • Xingya Li,
  • Zhe Liu,
  • Zhaoxia Dai,
  • Guohao Xia,
  • Xueqin Chen,
  • Yi Ba,
  • Chunmei Bai,
  • Qingshan Li,
  • Guangyu An,
  • Weiguo Hu,
  • Yinxiang Wang,
  • Andrea Wang-Gillam,
  • Yuli Ding,
  • Qiao Li,
  • Zhiyue Rao

摘要

Glecirasib (JAB-21822) is a new covalent oral KRAS-G12C inhibitor. This multicenter, single-arm phase 2b study assessed the efficacy and safety of glecirasib administered orally at 800 mg daily in patients with locally advanced or metastatic KRASG12C-mutated nonsmall-cell lung cancer. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee (IRC). Between 15 September 2022 and 28 September 2023, 119 patients with a median age of 62 years were enrolled. As of the data cut-off date on 28 March 2024, the ORR assessed by IRC was 47.9% (56/117; 95% confidence interval: 38.5–57.3%). The incidence of treatment-related adverse events (TRAEs) of any grade was 97.5% (116/119). The incidence of grades 3 and 4 TRAEs was 38.7% (46/119). A total of 5.0% (6/119) of patients discontinued the treatment due to TRAEs. No treatment-related deaths occurred. Glecirasib exhibited promising clinical efficacy and manageable safety profiles in these patient populations. ClinicalTrials.gov identifier: NCT05009329.